Clinical Investigation of the Next Generation Intraocular Lens

Johnson & Johnson (J&J)

Status: Completed

Conditions: Cataract

Treatments: Device: Control Monofocal Intraocular Lens: TECNIS Monofocal IOL; Device: Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03500198

SUR-IOL-652-2001

Details and patient eligibility

About

An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.

Full description

The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.

Enrollment: 247 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Minimum 22 years of age
• Bilateral cataracts for which posterior chamber IOL implantation has been planned
• Corneal astigmatism:
• Normal corneal topography
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits
• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
• Ability to understand and respond to a questionnaire in English

Exclusion criteria

• Irregular corneal astigmatism
• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
• Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
• Poorly-controlled diabetes
• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
• Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
• Desire for monovision correction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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247 participants in 2 patient groups

Investigational Device: Next Generation TECNIS IOL

Experimental group

Description:

Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL

Treatment:

Device: Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL

Control Device: TECNIS Monofocal IOL

Active Comparator group

Description:

Control Monofocal Intraocular Lens: TECNIS Monofocal IOL

Treatment:

Device: Control Monofocal Intraocular Lens: TECNIS Monofocal IOL